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Spots Global Cancer Trial Database for Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)

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Trial Identification

Brief Title: Single Dose Intravesical Apaziquone Postoperative in Patients Undergoing TURBT for Noninvasive Bladder Cancer (SPI-612)

Official Title: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Phase 3 Trial of Single-Dose Intravesical Apaziquone (EOquin®) as a Surgical Adjuvant Instilled in the Early Postoperative Period in Patients Undergoing Transurethral Resection for Noninvasive Bladder Cancer (Protocol SPI-612)

Study ID: NCT00598806

Conditions

Bladder Cancer

Study Description

Brief Summary: The purpose of this study was to evaluate the 2-Year Recurrence Rate of bladder cancer in randomized patients with tumor histology Ta, G1-G2 who received TransUrethral Resection of Bladder Tumor (TURBT) plus apaziquone versus those who received TURBT plus placebo.

Detailed Description: This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled study. Within 14 days of Screening, eligible patients underwent a TURBT during Visit 1 (Day 0) following which they were immediately randomized in a 1:1 ratio to receive either placebo or 4 mg apaziquone, instilled in a volume of 40 mL into the bladder within 6 hours from the end of the TURBT procedure. After a 60-minute retention period, study drug was drained from the bladder. A postoperative follow-up examination and review of the local pathology report were performed at Visit 2, which occurred 21 days (±10 days) after the TURBT (Week 3). * If the histology of the patient's tumor was confirmed as Ta, G1-G2 (ie, low grade according to World Health Organization \[WHO\]/International Society of Urologic Pathology \[ISUP\] classification), no further treatment was given and the patient was observed cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10). * If the histology of the patient's tumor was other than Ta, G1 or G2 (low grade \[WHO/ISUP classification\]), further treatment was given in accordance with current treatment guidelines, and the patient was followed up cystoscopically every 3 months through Year 2 for tumor recurrence (Visit 3 through Visit 10). All patients were to be followed for 2 years.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Advanced Urology Medical Center Clinical Trials, Anaheim, California, United States

Hal J. Bashein, D.O., West Palm Beach, Florida, United States

Urology Enterprises, Marietta, Georgia, United States

North Fulton Urology, Roswell, Georgia, United States

Hines VA Hospital, Hines, Illinois, United States

The Urology Center, Slidell, Louisiana, United States

Chesapeake Urology Research Associates, Baltimore, Maryland, United States

Chesapeake Urology Research Associates, Towson, Maryland, United States

William Beaumont Hospital, Royal Oak, Michigan, United States

PharmaTrials, Inc. - Male & Female Urology, Hillsborough, New Jersey, United States

PharmaTrials, Inc., Hillsborough, New Jersey, United States

Medical & Clinical Research Associates, LLC, Bay Shore, New York, United States

Urology Associates, PC, Manhasset, New York, United States

North Shore - LIJ Health System - The Arthur Smith Institute for Urology, New Hyde Park, New York, United States

Alliance Urology Specialists, Greensboro, North Carolina, United States

Piedmont Medical Research, Winston-Salem, North Carolina, United States

Center for Urologic Care, Bryn Mawr, Pennsylvania, United States

Medical University of South Carolina, Dept. of Urology, Charleston, South Carolina, United States

Urology Associates of South Texas, McAllen, Texas, United States

Salt Lake Research, Salt Lake City, Utah, United States

Adult and Pediatric Urologists, Alexandria, Virginia, United States

Prostate Cancer Institute, Calgary, Alberta, Canada

Lintor Medical, Inc., North Vancouver, British Columbia, Canada

Andreou Research, Surrey, British Columbia, Canada

Can-Med Clinical Research, Inc, Victoria, British Columbia, Canada

G. Steinhoff Clinical Research, Victoria, British Columbia, Canada

Queen Elizabeth II Health Sciences Centre, Halifax, Nova Scotia, Canada

The Male/Female Health and Research Center - Royal Court Medical Centre, Barrie, Ontario, Canada

Brantford Urology Research, Brantford, Ontario, Canada

G. Kenneth Jansz Medicine Professional Corporation, Burlington, Ontario, Canada

Urology Resource Centre, Burlington, Ontario, Canada

Kingston General Hospital / Queen's University, Kingston, Ontario, Canada

Urology Associates, Urologic Medical Research, Kitchener, Ontario, Canada

London Health Sciences Centre, London, Ontario, Canada

Mor Urology, Inc., Newmarket, Ontario, Canada

Dr. Bernard Goldfarb, North Bay, Ontario, Canada

Stanley Flax Medical Professional Corporation, North York, Ontario, Canada

The Fe/Male Health Centre, Oakville, Ontario, Canada

Orillia Urology Associates, Orillia, Ontario, Canada

Urotec, Oshawa, Ontario, Canada

ADA Medical Ltd., Peterborough, Ontario, Canada

AGT Research, Scarborough, Ontario, Canada

Urology & Male Infertility, Scarborough, Ontario, Canada

Toronto East General Hospital, Toronto, Ontario, Canada

Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada

University Health Network Princess Margaret Hospital, Toronto, Ontario, Canada

The Male Health Centre, Toronto, Ontario, Canada

Saint Joseph Health Center, Toronto, Ontario, Canada

UroLaval, Laval, Quebec, Canada

McGill Urology Associates, Montreal, Quebec, Canada

Ultra-Med, Inc., Pointe Clare, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Quebec, Canada

Centre hospitalier universitaire de Quebec, Quebec, , Canada

Uniwersytecki Szpital Kliniczny, Białystok, , Poland

Szpital Wojewódzki w Bielsku-Białej, Bielsko-Biała, , Poland

Akademickie Centrum Kliniczne - Szpital Akademii Medycznej w Gdańsku, Gdańsk, , Poland

Publiczny Specjalistyczny Zakład Opieki Zdrowotnej w Inowrocławiu, Inowrocław, , Poland

Szpital Miejski im. Prof. E. Michałowskiego, Katowice, , Poland

Świętokrzyskie Centrum Onkologii, Samodzielny Publiczny Zakład Opieki Zdrowotnej, Kielce, , Poland

Szpital Specjalistyczny w Kościerzynie, Kościerzyna, , Poland

Niepubliczny Zakład Opieki Zdrowotnej "Racławicka", Kraków, , Poland

Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie, Lublin, , Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej w Pabianicach, Pabianice, , Poland

Zakład Opieki Zdrowotnej Poznań - Stare Miasto, Poznań, , Poland

Szpital Kolejowy im. Dr med.. Włodzimierza Roeflera w Pruszkowie, Pruszków, , Poland

Samodzielny Publiczny Zakład Opieki Zdrowotnej, Wojewódzki Szpital Specjalistyczny nr 3, Rybnik, , Poland

Wojewódzki Szpital Specjalistyczny W Siedlcach, Siedlce, , Poland

Pomorska Akademia Medyczna, Szczecin, , Poland

Wojewódzki Szpital Specjalistyczny im Janusza Korczaka, Słupsk, , Poland

Centrum Medycznego Kształcenia Podyplomowego, Samodzielny Publiczny Szpital Kliniczny im. Prof. W. Orłowskiego, Warszawa, , Poland

Wojskowy Instytut Medyczny, Centralny Szpital Kliniczny MON, Warszawa, , Poland

Szpital Kliniczny Dzieciątka Jezus - Centrum Leczenia Obrażeń, Warszawa, , Poland

Centrum Onkologii im. Marii Skodowskiej-Curie, Warszawa, , Poland

Fundacja "Urologia", Międzyleski Szpital Specjalistyczny w Warszawie, Warszawa, , Poland

Akademicki Szpital Kliniczny im Jana Mikulicza-Radeckiego we Wrocławiu, Wrocław, , Poland

Wojewódzki Szpital Specjalistyczny we Wrocławiu, Ośrodek Badawczo Rozwojowy, Wrocław, , Poland

Uniwersytecki Szpital Kliniczny nr 2 Wojskowej Akademii Medycznej Uniwersytetu Medycznego w Łodzi - Centralny Szpital Weteranów, Łódź, , Poland

Contact Details

Name: Shanta Chawla, MD

Affiliation: Spectrum Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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